Category: NeuroSigma Inc
California medical device maker NeuroSigma lands FDA investigational device exemption to launch Phase III studies of its epilepsy treatment in support of U.S. approval.
NeuroSigma is one step closer to bringing its epilepsy treatment to U.S. markets with FDA approval to begin its Phase III clinical studies.
Currently only available for investigational use in the U.S., NeuroSigma's Monarch eTNS system is already on the shelves in Europe and Canada. Earlier studies have shown a 50% reduction in seizures for 2/5 of epilepsy patients treated, NeuroSigma said.
CircuLite won CE Mark approval in the European Union for its Synergy heart pump; EuroZone regulators also OK NeuroSigma's Monarch trigeminal nerve stimulation device for epilepsy and depression.
The European Union granted CE Mark approval to a pair of medical device companies, CircuLite and NeuroSigma, for their technologies designed to treat heart failure, epilepsy and depression.
Boston Scientific chief financial officer Jeffrey Capello joins the board of directors at fertility treatment start up OvaScience; Covidien shuffles the deck for vascular therapies; Orgenesis names new CEO, CFO, CSO; National Standards Authority of Ireland adds 5 to certification committee; plus more.
Boston Scientific (NYSE:BSX) executive vice president and chief financial officer Jeffrey Capello joined the board of directors at OvaScience, a Boston, Mass.-based start up developing infertility treatments.
Capello began working at Boston Scientific in 2008, landing the CFO seat in 2010. He oversees the company's global finance, information systems, business development and corporate strategy functions.
Cardiosolutions Inc. drums up $3.3 million of a hoped-for$6.5 million funding round for its catheter-based mitral valve repair technology.
Cardiosolutions Inc. landed about half of what it hopes will amount to a $6.5 million fundraising round, pulling in $3.3 million from eight un-named investors, according to a regulatory filing.
The Stoughton, Mass.-based company is a spinout from contract manufacturer STD Med, which early last year bought a new, 32,000-square-foot cleanroom to house Cardiosolutions and sister firm Spirus Medical Inc.
NeuroSigma Inc. spins out NSVascular on a licensing deal with the University of Calif.-Los Angeles to develop stents using UCLA's thin-film nitinol technology.
NeuroSigma Inc. spun out NSVascular Inc. to develop two stent lines using thin-film nitinol technology developed at the University of Calif.-Los Angeles under an exclusive licensing agreement.
Los Angeles-based NeuroSigma said its new subsidiary plans to develop one type of stent to treat brain aneurysms and another to treat peripheral artery disease.
PatientsLikeMe touts the results of a patient-initiated ALS-treatment study that indicates the benefits of social networking in clinical trials.
Social networking may someday become a part of clincal trials on medical devices and drugs.
A recent trial found that lithium carbonate didn't slow the progression of Lou Gehrig's disease, or amyotrophic lateral sclerosis (ALS), but the study also indicated that the use of a social network to enroll patients and report and collect data could facilitate future studies.